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Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569541
Recruitment Status : Completed
First Posted : October 6, 2015
Results First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Arrevus Inc.

Brief Summary:
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.

Condition or disease Intervention/treatment Phase
Refractory Bone or Joint Infections Drug: sodium fusidate Phase 2 Phase 3

Detailed Description:
Prospective, open-label, non-randomized, single-arm trial to evaluate the safety and effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint infections. Subjects enrolling in this study must have a refractory staphylococcal bone or joint infection that requires suppressive antibiotic therapy (e.g. having an infection that cannot be managed by complete removal of the infected bone or foreign material, a refractory infection not responding to previous treatment, or not being a candidate for long-term intravenous antibiotic therapy).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Randomized, Single-Arm, Multi-Center Study to Evaluate Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections in Subjects for Whom Chronic Antibiotic Suppressive Therapy is Indicated
Study Start Date : December 2015
Actual Primary Completion Date : October 17, 2017
Actual Study Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CEM-102 (Sodium fusidate)

1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:

  • 6 months of treatment; or
  • 24 months of treatment (if continued on chronic suppressive therapy)
Drug: sodium fusidate
Other Names:
  • CEM-102
  • fusidic acid




Primary Outcome Measures :
  1. Clinical Success at 6 Months [ Time Frame: 6 months after start of treatment ]

    Number of participants in the intent to treat (ITT) analysis set who meet all the criteria for clinical success at the 6-Month Visit.

    Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia



Secondary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Entire study period - up to 24 months ]

    Number of participants with TEAEs, SAEs, deaths, and discontinuations due to AEs.

    Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.


  2. Clinical Success at 9 Months [ Time Frame: 9 months after start of treatment ]

    Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 9-Month Visit.

    Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia


  3. Clinical Success at 12 Months [ Time Frame: 12 months after start of treatment ]

    Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 12-Month Visit.

    Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia


  4. Clinical Success at 15 Months [ Time Frame: 15 months after start of treatment ]

    Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 15-Month Visit.

    Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia


  5. Clinical Success at 18 Months [ Time Frame: 18 months after start of treatment ]

    Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 18-Month Visit.

    Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia


  6. Clinical Success at 21 Months [ Time Frame: 21 months after start of treatment ]

    Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 21-Month Visit.

    Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia


  7. Clinical Success at 24 Months [ Time Frame: 24 months after start of treatment ]

    Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 24-Month Visit.

    Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents between 12 and 18 years must weigh >60 kg
  • Bone or joint infection due to an inclusionary pathogen demonstrated from a culture from samples obtained within 6 weeks prior to enrollment
  • Not a candidate, as determined by the Investigator, for suitable alternative therapy
  • After completion of 1-2 weeks of the companion antibiotic, must be a suitable candidate for CEM-102 monotherapy for chronic treatment

Exclusion Criteria:

  • Requires concomitant treatment with OATP1B1 and OATP1B3 substrates, in particular, statins (HMG-CoA reductase inhibitors)
  • Known severe renal impairment, as indicated by estimated CrCl <30 mL/min (by Cockcroft-Gault calculation)
  • Evidence of significant liver disease: ALT >3 × ULN or direct bilirubin >ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569541


Locations
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United States, California
Fountain Valley, California, United States, 92708
San Dimas, California, United States, 91773
Sylmar, California, United States, 91432
Torrance, California, United States, 90502
United States, Florida
Tamarac, Florida, United States, 33321
United States, Illinois
Springfield, Illinois, United States, 62703
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Maryland
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Montana
Butte, Montana, United States, 59701
United States, New Jersey
Somers Point, New Jersey, United States, 08244
United States, North Carolina
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Haverford, Pennsylvania, United States, 19041
Malvern, Pennsylvania, United States, 19355
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Arrevus Inc.
Investigators
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Study Director: Robert Dobbins, MD, PhD Melinta Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Arrevus Inc.:
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Responsible Party: Arrevus Inc.
ClinicalTrials.gov Identifier: NCT02569541    
Other Study ID Numbers: CE06-302
First Posted: October 6, 2015    Key Record Dates
Results First Posted: January 30, 2020
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arrevus Inc.:
fusidic acid
prosthetic joint infections
bone infections
osteomyelitis
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Fusidic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action